Observational study of Insulin Glargine 300 u/ml performed before, during and after period of Ramadan, in patients with Type 2 Diabetes Mellitus
- Conditions
- Health Condition 1: E119- Type 2 diabetes mellitus without complications
- Registration Number
- CTRI/2019/02/017636
- Lead Sponsor
- Sanofi India Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Patient with T2DM treated with insulin glargine U300, as basal insulin for at least 8 weeks prior to inclusion in the study, and who plans to continue to be on insulin glargine U300, during the period of Ramadan.
- Patient who intends to fast for at least 15 days during Ramadan.
- Patient willing to sign written informed consent.
- Patient able and willing to perform SMPG according to physician instruction.
- Patient willing to complete study patient diary (for SMPG, insulin dose, and hypoglycemia) according to physicianâ??s recommendation.
- Age <18 years old or
- Pregnant or Breastfeeding women.
- Diabetes other than T2DM.
- Treatment with basal bolus or premix regimen, in the 6 months prior to start of treatment with insulin glargine U300.
- Use of any investigational drug within 1 month or 5 half-lives, whichever is longer, prior to selection visit.
- Known hypersensitivity/intolerance to insulin glargine U300 or any of its excipients.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the percentage of patients experiencing at least 1 episode of severe and/or symptomatic documented hypoglycemia with plasma glucose (PG) â?¤70 mg/dL (3.9 mmol/L) during the Pre-Ramadan, Ramadan, and Post-Ramadan periods.Timepoint: 5 months including one month of fasting in Ramadan
- Secondary Outcome Measures
Name Time Method To assess the incidence (percentage of patients with event) and event rate (frequency of occurrence) of symptomatic hypoglycemic episodes during the Pre-Ramadan, Ramadan, and Post-Ramadan periods. <br/ ><br>To describe glycemic control parameters. <br/ ><br>To describe overall safety and tolerability of the treatment throughout the studyTimepoint: 5 months including one month of fasting in Ramadan